Events

D-10 Rack Loader. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Rad Laboratories Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-00099-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00099-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    There is a potential for a sample and result to be mismatched when running in the d-10 rack loader configuration. this means that a patient result may be assigned to an incorrect sample id. while only two instances have been reported, bio-rad wants users to be aware of the possibility.
  • 조치
    Bio-Rad is investigating the reported issue and preparing a permanent solution. In the interim, users are advised to not skip positions within the rack. While reviewing results, check the Daily Summary for the following: A. Confirm that the number of results equals the total number of samples run. B. Confirm that injection numbers (I#) within an individual rack (R#) are consecutive. C. Confirm that any sample that was assigned an auto-generated Sample ID is actually missing a barcode label on the sample tube. Bio-Rad Laboratories will release a follow-up communication providing a permanent solution upon completion of a thorough investigation.

Device

D-10 Rack Loader. An in vitro diagnostic medical device (IVD).
  • 모델명 / 제조번호(시리얼번호)
    D-10 Rack Loader. An in vitro diagnostic medical device (IVD).Catalogue Number: 220-0600ARTG Number: 212703
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd